Pre-Conference Biomarker Focus Day
Tuesday, January 28, 2025
8:30 am Check-In & Coffee + Light Breakfast
8:55 am Chair’s Opening Remarks
UNLOCKING PRECISION: IDENTIFYING EFFECTIVE BIOMARKERS FOR DDR PATHWAYS
9:00 am Exploring Oncogenic Stress & DNA Repair Defect as Biomarkers for DDR Therapies
Synopsis
- Understanding how both replication stress caused by oncogenic mutations and DNA repair mutations increase reliance on cell cycle checkpoint regulators and DNA repair proteins to maintain genome integrity
- Assessing how inhibition of these cell cycle checkpoints and DNA repair proteins in the context of such cancer-associated mutations leads to more selective genome destabilization and killing of cancer cells compared to normal, unmutated cells
- Identifying the cancer-associated mutations that cause sensitivity to these inhibitors and how they can enhance the therapeutic potential of these drugs and decrease toxicity to normal tissues
9:30 am Single Stranded DNA Gaps Denotes Sensitivity to DDR Inhibitors, Identifies Effective Combination Therapies & Screens for Novel DDR Inhibitors
Synopsis
- Assessing how ssDNA Gaps in cancer are a rapid, reliable, and more robust biomarker than HRD score to stratify patients likely to benefit from DDR-targeted cancer therapy
- Exploring the shift in the ssDNA Gap burden indicates DDR pathway(s) alteration
- Measuring ssDNA Gap burden identifies effective DDRi combinations and novel anticancer therapeutics
10:00 am Morning Break & Refreshments
ELEVATING PHARMACODYNAMIC BIOMARKERS & PIONEERING NOVEL BIOMARKER STRATEGIES
10:45 am Imaging Biomarkers to Guide PARP Inhibitors & DDR Therapies
Synopsis
- Quantifying PARP inhibitor binding sites and assessing drug target engagement with imaging biomarkers as predictive tools and to predict and guide dose optimization
- Reviewing other imaging markers that may be helpful to monitor treatment efficacy for DDR-targeted drugs
- Uncovering PARP-targeted radiopharmaceutical theranostics
11:15 am Harnessing Single-Cell Proteomics to Unlock Novel DDR Biomarkers
Synopsis
- Investigating how cutting-edge single-cell proteomics is driving biomarker discovery in DDR research
- Evaluating the potential of single-cell technologies to identify novel biomarkers for DDR therapies
- Examining the challenges of implementing single-cell proteomics in clinical settings for DDR biomarker development
11:45 am Coming Full Circle, Identification, & Therapeutic Targeting of Extrachromosomal DNA
Synopsis
- Discovery and utilization of CHK1 and RNR inhibitors for the treatment of oncogene amplified cancers
- Establishment of a diagnostic for identification of patients with amp/ecDNA containing tumors
- Addressing the clinical unmet need presented by oncogene amplified tumors utilizing ecDTx therapies
12:15 pm Lunch & Networking
1:30 pm Optimizing Biomarker-Driven Clinical Trial Design for DDR Inhibitors: Navigating Regulatory Challenges & Accelerating Approvals
Synopsis
- Utilizing biomarkers to enrich DDR inhibitor trials by targeting subgroups with defective DNA repair for enhanced therapeutic response, considering the impact of new EU in vitro diagnostic regulations (IVDR) on biomarker study implementation and approvals
- Applying advanced statistical methods to address challenges in subgroup characterization, demonstrating efficacy in both biomarker-positive and negative populations
- Aligning trial designs with FDA guidelines, focusing on biomarker-defined populations to streamline and expedite DDR inhibitor approvals
REVOLUTIONIZING SUCCESS: BIOMARKER STRATEGY FOR STREAMLINING CLINICAL DEVELOPMENT
2:00 pm Roundtable: Navigating the Trade-Offs of Multi-Biomarker Approaches for Personalized Cancer Therapies to Drive DDR Inhibitor Clinical Success
Identification & Translation of Effective Biomarkers for DNA Damage Repair Targets
- How do multiple biomarkers, such as those related to homologous recombination (HR) defects and PARP sensitivity, facilitate the identification of novel cancer vulnerabilities in preclinical models?
- What innovative strategies can be employed to overcome challenges in translating genomic and functional assays of DNA repair into clinically relevant biomarkers that accurately predict treatment responses?
Bridging the Gap: Challenges in Clinical Implementation
- In what ways can multi-biomarker approaches, including insights from DNA damage kinases like ATR, CHK1, and WEE1, reshape clinical pathways and enhance precision medicine for DDR inhibitor therapies?
- How can clinicians effectively utilize biomarkers of sensitivity and resistance to navigate the complexities of treatment regimens, ultimately improving patient outcomes and reducing adverse effects?
Strategic Priorities: Shaping Industry-Wide Biomarker Development for DDR-Targeting Therapies
- Should the industry prioritize the development of broadly applicable biomarkers or focus on highly specific multi-biomarker strategies that consider the complexities of the DNA damage response?
- How can stakeholders collaborate to address the logistical challenges of developing and implementing biomarkers that guide the use of DDR inhibitors, including current clinical trial frameworks?
3:00 pm Roundtable Feedback Panel
Synopsis
- Following the separate roundtable discussions, this session is dedicated for the roundtable leaders to share insights, outcomes, and further questions raised on each table
- This will be a panel format taking audience questions to close off the day
- Building on earlier talks about oncogenic stress, ssDNA gaps, and clinical trial optimization, this round-up will leave the audience with actionable insights to navigate the complexities of integrating biomarkers, enhancing efficacy, and driving clinical success with DDR inhibitors
3:30 pm Chair’s Closing Remarks
3:35 pm End of Biomarker-Focused Day
